U.S. patent number 6,688,497 [Application Number 10/367,586] was granted by the patent office on 2004-02-10 for apparatus and method for tissue rinse.
Invention is credited to Ketan C. Mehta.
United States Patent |
6,688,497 |
Mehta |
February 10, 2004 |
**Please see images for:
( Certificate of Correction ) ** |
Apparatus and method for tissue rinse
Abstract
An apparatus and method for preparing a pH balanced saline
solution and using the saline solution for rinsing tissue. The
apparatus includes a container having flexible sidewalls and an
opening for a removable cap. The cap has a rounded convex upper
portion curving away from an opening at the cap's uppermost surface
and has a conduit in the cap's interior, which conduit extends into
the container when the apparatus is fully assembled or is connected
to a tube that extends in the container. A saline solution is
prepared by adding sodium chloride and sodium bicarbonate to
distilled or boiled water. The sidewalls of the container are
compressed to urge the saline solution through the conduit, or tube
and conduit, and through the opening in the cap. The solution can
be used to rinse tissue, such as a mucus membrane, eye tissue, skin
or tissue inside an oral cavity.
Inventors: |
Mehta; Ketan C. (Santa Rosa,
CA) |
Family
ID: |
32907627 |
Appl.
No.: |
10/367,586 |
Filed: |
February 14, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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845759 |
Apr 30, 2001 |
6520384 |
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Current U.S.
Class: |
222/211;
222/215 |
Current CPC
Class: |
A61H
35/04 (20130101); A61K 9/0048 (20130101); A61M
3/02 (20130101); A61M 3/0262 (20130101); A61M
11/02 (20130101); A61M 15/00 (20130101); B65D
1/323 (20130101); A61M 2210/0618 (20130101); A61M
2210/0625 (20130101) |
Current International
Class: |
A61H
35/00 (20060101); A61H 35/04 (20060101); A61M
15/00 (20060101); A61M 11/00 (20060101); A61M
11/02 (20060101); A61M 3/00 (20060101); A61M
3/02 (20060101); B65D 1/32 (20060101); B65D
1/00 (20060101); B65D 037/00 () |
Field of
Search: |
;222/207,211-213,215,420-422 ;141/22-24,379-381 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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296 02 605 |
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Apr 1996 |
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DE |
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881807 |
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Nov 1961 |
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GB |
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WO 96/29044 |
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Sep 1996 |
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WO |
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Other References
NeilMed, "Sinus Rinse", 2000, London, XP-002207679, p. 7, 14. .
Dr. Grossan Sinus Irrigator.RTM. Tip. Datasheet [online] Hydro Med
Products, Jul. 19, 2000 [retrieved on Apr. 26, 2001]. Retrieved
from the Internet: <URL:www.sinus-relief.com/whatsirr.html>.
.
SinuCleanse.RTM. .COPYRGT.2000. Datasheet [online] Med-Systems,
Inc. Jan. 27, 2001 [retrieved on Jul. 10, 2001]. Retrieved from the
Internet: <URL:www.sinucleanse.com/sinu2.html>. .
Sinus-Rinse.TM. .COPYRGT.2001. Datasheet [online] SINUS-RINSE.TM.
[retrieved on Jul. 10, 2001]. Retrieved from the Internet:
<URL.www.sinusrinse.com>. .
Using the Pulsatile Nasal Irrigator. Datasheet [online] Hydro Med
Inc. Aug. 7, 2000 [retrieved on Apr. 27, 2001]. Retrieved from the
Internet: <URL:www.ent-consult.com/nasal_irr_use.html>. .
Breathe Ease .COPYRGT.2000. Datasheet [online] Hydro Med Inc. Apr.
16, 2000. 6 pages. .
Entsol.RTM., Datasheet [online], Retrieved from the Internet:
<URL: www.entsolwash.com>. [undated; pre-Apr. 30, 2001].
.
"RhinoCare.RTM. Nasal Douche" brochure, Siemens & Co. (5 pages.
English translation 12 pages.) (pre-Apr. 30, 2001). .
Tomooka, Lance T., et al. "Clinical Study and Literature Review of
Nasal Irrigation" The Laryngoscope, .COPYRGT.2000 The American
Laryngological, Rhinological and Otological Society, Inc. pgs.
1189-1193, Jul. 2000. .
Got a medical concern?--Ethicare--Nasal Irrigators.TM. 2001,
Datasheet [online] Ethicare, Jan. 11, 2001, retrieved from the
Internet: <URL www.ethicare.com>. .
Rhinotip Irrigation Regimen .COPYRGT.2000 , 1999. Datasheet
[online] Comtech Solutions. Retrieved from the Internet: www.
sinushealth.com. .
Kehtan C. Mehta M.D., Sinus Rinse (A Complete Saline Nose Wash
Kit), .COPYRGT. NeilMed Products, 2000, Santa Rosa, CA..
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Primary Examiner: Jacyna; J. Casimer
Attorney, Agent or Firm: Fish & Richardson P.C.
Parent Case Text
CROSS REFERENCE TO RELATED APPLICATIONS
This is a continuation-in-part of U.S. Ser. No. 09/845,759, filed
Apr. 30, 2001, now U.S. Pat. No. 6,520,384 which is incorporated by
reference in its entirety and which is the basis of a claim of
priority under 35 U.S.C. .sctn. 120.
Claims
What is claimed is:
1. A method for rinsing eye tissue, the method comprising:
preparing an iodine-free saline solution having a concentration in
the range of approximately 0.9% to 1% by dissolving a measured
amount of sodium chloride and sodium bicarbonate, the amount being
approximately 39 parts sodium chloride and approximately 1 to 2
parts sodium bicarbonate, into a measured amount of water in a
container, wherein the container has flexible sidewalls; connecting
a cap having: a cylindrical lower portion, a rounded convex upper
portion curving away fron an axially aligned opening from which a
liquid is dispensed located in the uppermost surface of the upper
portion and curving downwardly to join the cylindrical lower
portion, an open lower end, and a tubular conduit connected to the
uppermost interior surface of the upper portion and having a hollow
center axially aligned with the opening located in the upper
portion and wherein the conduit extends into the container; and
compressing the sidewalls of the container to urge the saline
solution out of the container and causing the saline solution to
come in contact with the eye tissue.
2. The method of claim 1, wherein the saline solution has a pH in
the range of approximately 7.3 to 7.7.
3. A method for rinsing tissue located inside an oral cavity, the
method comprising: preparing an iodine-free saline solution having
a concentration in the range of approxixnately 0.9% to 1% by
dissolving a measured amount of sodium chloride and sodium
bicarbonate, the amount being approximately 39 parts sodium
chloride and approximately 1 to 2 parts sodium bicarbonate, into a
measured amount of water in a container, wherein the container has
flexible sidewalls; connecting a cap having: a cylindrical lower
portion, a rounded convex upper portion curving any from an axially
aligned opening from winch a liquid is dispensed located in the
uppennost surface of the upper portion and curving downwardly to
join the cylindrical lower portion, an open lower end, and a
tubular conduit connected to the uppermost interior surface of the
upper portion and having a hollow center axially aligned with the
opening located in the upper portion and wherein the conduit
extends into the container; and compressing the sidewalls of the
container to urge the saline solution out of the container and
causing the saline solution to come in contact wit the tissue
located inside an oral cavity.
4. The method of claim 3, wherein the saline solution has a pH in
the range of approximately 7.3 to 7.7.
5. A method for rinsing eye tissue, the method comprising:
preparing an iodine-free saline solution having a concentration in
the range of approximately 0.9% to 1% by mixing a measured amount
of sodium chloride and sodium bicarbonate, the amount being
approximately 39 parts sodium chloride and approximately 1 to 2
parts sodium bicarbonate, with a measured amount of distilled water
and dissolving the sodium chloride and sodium bicarbonate in the
water; and dispensing the saline solution to rinse the eye
tissue.
6. The method of ciaim 5, wherein the saline solution has a pH in
the range of approximately 7.3 to 7.7.
7. A method for rinsing tissue located inside an oral cavity, the
method comprising: preparing an iodine-free saline solution having
a concentration in the range of approximately 0.9% to 1% by mixing
a measured amount of sodium chloride and sodium bicarbonate, the
amount being approximately 39 parts sodium chloride and
approximately 1 to 2 parts sodium bicarbonate, with a measured
amount of distilled water and dissolving the sodium chloride and
sodium bicarbonate in the water; and dispensing the saline solution
to rinse the tissue located inside an oral cavity.
8. The method of claim 7, wherein the saline solution has a pH in
the range of approximately 7.3 to 7.7.
Description
TECHNICAL FIELD
This invention relates to methods and apparatus for rinsing
tissues.
BACKGROUND
A body includes a number of sensitive tissues, for example, eye
tissue, mucous membranes of the nasal passages and sinuses, and the
interior of the mouth. These tissues are subject to bacterial
growth, ulcers, irritation and disease.
Sinusitis is an inflammation of the mucosa of various sinuses,
which are located around the nasal passages. Rhinitis is an
inflammation of the mucosa of a nasal passage. Sinusitis and
rhinitis can be caused by cold viruses, allergies to various
allergens, smoking, bacterial or fungal infections, nasal polyps,
deviated nasal septums and non-allergic hypersensitivities.
Symptoms of rhinitis include: stuffy nose, runny or drippy nose,
scratchy throat and dry cough. Symptoms of sinusitis are more
severe than the symptoms of rhinitis. Acute and chronic sinusitis
occurs when the sinuses are inflamed and the ostia, or passages,
are blocked. Symptoms include: nasal congestion; runny or stuffy
nose; white, yellow or green discharge; headache; night time cough;
pain in the upper jaw or teeth; persistent fatigue; fever; loss of
sense of smell or taste; and sometimes serious infections like
meningitis, brain abscess or ear infections.
As indicated above, allergies can cause rhinitis and sinusitis.
Allergens are organic particles that attach to the nasal mucosa or
respiratory mucosa and lead to the development of an antibody,
which subsequently creates a series of chemical reactions leading
to symptoms. Every individual's reaction to allergen exposure is
different. Indoor allergens include dust mites, mold, pet dander
and cockroaches. Outdoor allergens include pollens, grass and mold.
Other substances such as cigarette smoke, perfumes and aerosol
sprays are irritants that can worsen allergy and sinus symptoms.
Allergens can also irritate the eyes and cause itching, tearing,
redness, and swelling of the eyelids.
There are various methods to treat the symptoms of, or to cure,
sinus and ocular disease, including surgery. An effective nasal
rinse can significantly reduce or permanently cure the symptoms of
nasal allergies and sinus disease. Saline nasal irrigations have
been used and mentioned in medical textbooks going back many years.
A wide variety of techniques have been described, including
swimming in salt water, which often results in some degree of
inadvertent nasal salt water irrigation. For persons suffering from
allergies irritating the eye, a saline solution can flush the
allergens out of the eye.
Nasal rinsing or lavage is a treatment for rhinitis and sinusitis
that uses a saline solution dispensed into the nasal passage to
cleanse and wash away mucus and allergy creating particles and
irritants. Lavaging allows the sinuses to drain normally and
reduces the inflammation of the mucus membrane.
Oral rinsing with a saline solution can be used for therapeutic
purposes. Similarly, a saline solution can also be used to relieve
dry eyes, conjunctivitis, or flush foreign materials out of the
eye, and can be used on a daily basis.
Prepared saline solution is available for uses including nasal
lavage, oral rinse, and ocular drops, however a bottle filled with
saline solution can be quite expensive. Alternatively, saline
solution can be prepared at home using household ingredients.
However, there is a concern for cleanliness and contamination, and
for ensuring that the proper concentration level and acidity is
achieved. Thus, there is a need for a method for preparing a saline
solution having a consistent and appropriate concentration that is
simple, inexpensive and not easily contaminated.
Nasal rinsing equipment currently available includes various types
of dispensers that can be filled with a saline solution and which
are then injected into the user's nasal passage. Conventional nasal
rinsing equipment can be crude and may only be suitable for users
having a certain size nostril. For proper use, the dispensing tip
should comfortably seal against a user's nostril. Equipment having
a dispenser tip designed for a certain size nostril can be useless
for someone with a smaller nostril, in particular children, such as
the nasal rinse equipment described in U.S. Pat. No. 5,806,723 for
a DEVICE FOR LAVAGING. Thus, there is a need for equipment having a
dispenser tip that effectively and comfortably seals against human
nostrils of varying sizes, including nostrils of children.
Another problem with current nasal lavaging equipment is that the
configuration of the dispensing tip can cause the saline solution
to be dispensed into the nasal passage without sufficiently
dispersing before reaching the back of the nasal passage, resulting
in an uncomfortable or painful sensation for the user. There is a
need for a dispenser tip configured to allow the saline solution to
disperse sufficiently before reaching the back of the nasal
passage.
Conventional lavaging equipment includes dispenser tips that are
compatible with power operated oral irrigators. The dispenser tip
and oral irrigator can be used to direct the irrigation solution to
the mucus membrane of the mouth or throat. However, the dispenser
tips are typically only compatible with a certain model of oral
irrigator, such as the dispenser tip described in U.S. Pat. No.
3,847,145 for a NASAL IRRIGATION SYSTEM.
For the foregoing reasons, there is a need for an apparatus and
system for preparing and dispensing a saline solution that is
simple to use, capable of being prepared and administered in most
any location, relatively inexpensive and suitable for use by
persons having nostrils of varying sizes, and that is compatible
with most commercially available oral irrigators.
SUMMARY
The present invention provides methods and apparatus for rinsing
tissue with a saline solution. In general, in one aspect, the
invention features a system for rinsing tissue that includes an
iodine-free saline solution for rinsing tissue and an apparatus for
dispensing the saline solution. The saline solution includes
approximately 39 parts sodium chloride and approximately 1 to 2
parts sodium bicarbonate dissolved in water. The apparatus includes
a cap and a container for holding the saline solution. The cap has
a cylindrical lower portion; a rounded convex upper portion curving
away from an axially aligned opening, from which a liquid is
dispensed, located in the uppermost surface of the upper portion
and curving downwardly to join the cylindrical lower portion; an
open lower end; and a tubular conduit connected to the uppermost
interior surface of the upper portion, the conduit having a hollow
center axially aligned with the opening located in the upper
portion. The container has flexible sidewalls and an axially
aligned neck having an open end. The lower portion of the cap and
the neck of the container are configured to join together with a
liquid tight connection.
In general, in another aspect, the invention features a system for
rinsing tissue, including a mixture for preparing a saline solution
and an apparatus for dispensing the saline solution onto the
tissue. The mixture includes approximately 39 parts sodium chloride
and approximately 1 to 2 parts sodium bicarbonate, and is dissolved
in water to form a pH balanced, iodine-free saline solution. The
saline solution has a pH in the range of approximately 7.3 to
7.7.
In general, in another aspect, the invention features a method for
rinsing tissue. The method includes preparing an iodine-free saline
solution having a concentration in the range of approximately 0.9%
to 1% by dissolving a measured amount of sodium chloride and sodium
bicarbonate, the amount being approximately 39 parts sodium
chloride and approximately 1 to 2 parts sodium bicarbonate, into a
measured amount of water in a container with flexible sidewalls.
The method further includes connecting a cap to the container. The
cap has a cylindrical lower portion, a rounded convex upper portion
curving away from an axially aligned opening from which a liquid is
dispensed located in the uppermost surface of the upper portion and
curving downwardly to join the cylindrical lower portion, an open
lower end, and a tubular conduit connected to the uppermost
interior surface of the upper portion and having a hollow center
axially aligned with the opening located in the upper portion and
wherein the conduit extends into the container. The sidewalls of
the container are compressed to urge the saline solution out of the
container and cause the saline solution to come in contact with the
tissue.
In general, in another aspect, the invention features a method for
rinsing tissue. The method includes preparing an iodine-free saline
solution and dispensing the solution to rinse the tissue. The
iodine-free saline solution has a concentration in the range of
approximately 0.9% to 1%, and is prepared by mixing a measured
amount of sodium chloride and sodium bicarbonate, the amount being
approximately 39 parts sodium chloride and approximately 1 to 2
parts sodium bicarbonate, with a measured amount of water and
dissolving the sodium chloride and sodium bicarbonate in the
distilled water.
Implementations of the invention may include one or more of the
following. The tissue can be a mucus membrane, eye tissue, skin, or
tissue inside an oral cavity. The saline solution can be isotonic,
and can have a saline concentration in the range of approximately
0.9% to 1%. The saline solution has a pH in the range of
approximately 7.3 to 7.7. The exterior surface of the lower portion
of cap can include rounded, vertical ridges. The opening in the cap
can be between 2.5 mm and 4.25 mm in diameter. The conduit can have
a slightly decreasing exterior diameter from the top to the bottom.
The liquid tight connection between the cap and the neck can be a
threaded connection. The container can have a marking to indicate
the liquid level and be made of transparent material.
Advantages of the invention include one or more of the following.
An apparatus is provided that can be used as a nasal rinse by
children as well as adults. The apparatus includes a cap design
that will provide an effective seal against the nostril of a child
or adult. The cap can be used in conjunction with a power driven
oral irrigator for performing a nasal, oral, or throat rinse. A
flexible tube is provided that can be connected to most
commercially available oral irrigators. The irrigation apparatus is
simple to use, simple to clean, and inexpensive to replace. The
user can inspect all parts of the apparatus to ensure cleanliness.
Further, the user can sterilize the apparatus in the home using a
microwave or boiling water to kill any bacteria on the surfaces of
the apparatus.
A nasal or ocular rinse can be performed without having to bend the
neck back and look upwards, as is the case with irrigation systems
that rely on gravity to dispense the solution. This feature is
particularly advantageous to persons who experience dizziness in
this position, in particular elderly persons.
Another advantage of the rinse is that the mixture allows an
iodine-free isotonic saline solution to be conveniently prepared
that is pH balanced to the mucous membranes and tissue the solution
would generally come into contact with. As such, the solution does
not create a burning sensation when it comes in contact with said
tissues. Generally, isotonic solutions are more comfortable and
produce fewer negative sensations than hypotonic and hypertonic
solutions when brought in contact with tissues. Greater comfort
increases both patient tolerance of the rinsing solution and
compliance with a course of treatment.
The details of one or more embodiments of the invention are set
forth in the accompanying drawings and the description below. Other
features, objects, and advantages of the invention will be apparent
from the description and drawings, and from the claims.
DESCRIPTION OF DRAWINGS
FIG. 1 is a side view of a dispenser assembly.
FIG. 2 is a side view of the dispenser assembly of FIG. 1 with the
cap partially removed.
FIG. 3 is a cross-sectional view of the dispenser assembly of FIG.
1.
FIG. 4 is a cross-sectional view of the cap of FIG. 1.
FIG. 5 is a cross-sectional view of a cap with an extended
conduit.
Like reference symbols in the various drawings indicate like
elements.
DETAILED DESCRIPTION
Referring now to FIG. 1, an apparatus for performing a tissue rinse
using a saline solution is shown. A dispenser assembly 10 includes
a container 30, a cap 20 and a tube 35 connected to the interior
portion of the cap 20 and extended into the container 30. The cap
20 can be removed from the container 30 by rotating the cap 20
(e.g., counter-clockwise), to allow the container 30 to be filled
with a saline solution 40.
Referring now to FIGS. 2 through 4, the apparatus will be described
in greater detail. The container 30 has flexible sidewalls that can
be easily compressed by a hand to force the saline solution 40
through the tube 35 and through an opening 15 at the top of the cap
20, when the cap 20 is secured to the container 30. The uppermost
portion of the container 30 includes a neck 45 that can include
threads 50 to provide a tight connection to the cap 20 to prevent
the escape of saline solution 40. However, attachment of cap 20 to
container 30 can be accomplished in any convenient fashion that
allows for removability and which maintains a liquid tight seal.
Other methods for attachment can include a ring and groove
assembly, a compression-fitting cap, exterior clamps or the like.
The container 30 can include a marking 32 to indicate a liquid
level. The marking 32 can be in any convenient form such as a
printed line, a groove, a ring or the like. The container 30 can be
made of a transparent material, such as a low-density
polypropylene, so the amount of saline solution 40 is visible and
the container 30 can be inspected for cleanliness. The container 30
should be able to withstand the heat of lukewarm to hot water and
should be microwave safe to allow convenient heating of the
contents of the container 30.
The cap 20 is hollow. The exterior of cap 20 has a cylindrically
shaped lower portion and a conically shaped upper portion. The cap
20 has a lower opening 75 to secure cap 20 onto container 30 and an
upper opening 15 at the apex of the conically shaped upper portion
for expulsion of the saline solution 40 from the cap 20. The
cylindrical lower portion of the exterior surface of cap 20 can
include rounded, vertical ridges 25 to allow a user to grip the cap
20 when either securing the cap 20 onto, or removing the cap 20
from, the neck 45 of the container 30. If the user employs the
apparatus for a nasal rinse, the conical upper portion of the
exterior surface of cap 20 includes a smooth finish to allow a
comfortable and effective seal against a user's nostril.
The exterior of the conical upper portion of cap 20 immediately
slopes downward from opening 15 to the ridges 25. The exterior
shape of a longitudinal cross-section of the upper portion of cap
20 can be a curve formed by the combination of at least three arcs.
The uppermost portion of the curve can be an arc that is a portion
of a circle having a first radius and the side portions of the
curve can be arcs that are portions of a circle having a second
radius. In the example of a cap 20 having a total height of
substantially 40 mm and an exterior diameter at its widest point of
substantially 29 mm, the first radius is substantially 10 mm and
the second radius is substantially 30 mm. In another
implementation, the exterior shape of a longitudinal cross-section
of the upper portion of cap 20 can be elliptical.
The conical shape of the upper portion of cap 20 allows the cap 20
to be inserted into and sealed against the nostril of either a
child or an adult, even though an adult typically has a relatively
larger nostril. In the case of an adult, the cap 20 is inserted
slightly further into the nasal passage before an effective seal is
achieved.
The interior of cap 20 can form a first cylinder 52 extending from
the lower surface of cap 20 to a height substantially one half of
the total height of cap 20. The surface of substantially the lower
quarter of the first cylinder 52 is smooth and the surface of the
remainder of the first cylinder 52 can have threads 60 to permit a
tight, threaded connection to the neck 45 of the container 30. The
interior of cap 20 can form a second cylinder 54 extending from the
top of the first cylinder 52 to a height substantially one quarter
of the total height of cap 20. The second cylinder 54 has a smaller
diameter than the first cylinder 54, thereby forming a lower
surface 80 of the second cylinder 54, which lower surface 80 abuts
the upper surface of the neck 45 of the container 30 when the cap
20 is secured onto container 30. The interior of cap 20 further
forms a cavity having interior walls 56 slanting or curving from
the top of the second cylinder 54 to the top of the exterior of a
conduit 55 extending vertically downwards from opening 15.
The opening 15 leads into a conduit 55 that extends vertically from
opening 15 downwards into the interior of cap 20. The exterior
diameter of the conduit 55 gradually tapers from the diameter at
the top of conduit 55 (closest to opening 15) to a lesser diameter
at the bottom of conduit 55. The interior diameter remains
substantially constant the entire length of the conduit 55. The
tapered exterior of conduit 55 allows tube 35 to be forced over the
top of the exterior of conduit 55 to form a snug fit. However,
attachment of tube 35 to conduit 55 can be accomplished in any
convenient fashion, including the addition of a ring (not shown)
around the exterior of conduit 55 to effectively lock tube 35 onto
conduit 55 once tube 35 is forced over the ring.
The diameter of opening 15 affects the flow rate of the saline
solution 40 out of the cap 20. If the opening 15 is too small when
the dispenser assembly 10 is used for nasal rinsing, the saline
solution 40 will enter a user's nasal passage at such a velocity
that the stream of saline solution 40 will not sufficiently
disperse before reaching the rear wall of the user's nasal cavity
and the force at which the saline solution 40 impacts the rear wall
of the user's nasal cavity will cause a jabbing sensation. If the
opening 15 is too large, the saline solution 40 will not exit the
cap 20 with enough force to reach the rear wall of a user's nasal
cavity. In one implementation, the diameter of opening 15 is made
to be no larger than substantially 4.25 mm and no smaller than
substantially 2.5 mm to allow the saline solution 40 to exit the
cap 20 with enough force both to fully irrigate the nasal passage
and to sufficiently disperse before reaching the rear wall of the
user's nasal cavity to minimize any user discomfort. The conical
shape of the upper portion of cap 20 allows an effective seal to be
formed against a nostril being at least as large as the opening 15.
The diameter of opening 15 is sized such that an effective seal can
be formed against the nostril of a child as well as an adult.
The cap 20 can be constructed from a rigid plastic such as
low-density polypropylene. Alternatively, cap 20 can be constructed
from any other non-toxic rigid substance, including stainless
steel. The cap 20 can be substantially 40 mm in height and have an
exterior diameter at its widest point of substantially 29 mm.
When dispenser assembly 10 is fully assembled, tube 35 can be
connected to conduit 55 and cap 20 is secured to container 30. Tube
35 extends into the interior of container 30, the lower surface of
tube 35 being substantially half an inch above the base 70 of
container 30. The tube can be made of a latex free, non-toxic,
strong and flexible material such as polyurethane. For some
purposes, such as eye irrigation where gravity can be relied upon,
the dispenser assembly 10 can be used without the tube 35.
Referring now to FIG. 5, in another implementation, the cap and
tube assembly can be a single unit. Cap 90 is similar in shape to
cap 20, but modified such that conduit 56 extends a length
comparable to the length of tube 35. The cap 90 can be made of a
rigid plastic such as a low density polyethylene. Cap 90 can be
connected to container 30 in the same manner as described above
with reference to cap 20.
The dispenser assembly 10 can also include a plug or stopper (not
shown) that fits into conduit 55 or conduit 56 through opening 15,
to retain the saline solution 40 in the container 30 to permit
transporting of the dispenser assembly 10 without leakage of the
saline solution 40. The connection of the plug to cap 20 or cap 90
could be by any convenient means including a compression-fit or
threaded connection.
The saline solution 40 can be prepared by dissolving sodium
chloride (NaCl) and sodium bicarbonate (NaHCO.sub.3) in water.
Preferably distilled water is used, but purified or clean tap water
can also be used. If purified or clean tap water is used, it can be
boiled. Boiled tap water typically has a pH of anywhere between 6
and 8. Distilled water typically has a pH of below 6.5 Preparing a
saline solution as described below yields a solution having a pH in
the range of approximately 7 to 8, with variations due to the pH of
the water used to prepare the solution, which as stated above can
vary between 6 and 8. Preferably distilled water is used and a
saline solution having a pH in the range of approximately 7.3 to
7.7 is prepared. The saline solution is therefore pH balanced to
human tissue, which typically has a pH of 7.4.
Packets containing a mixture of NaCl and NaHCO.sub.3 for preparing
an isotonic saline solution pH balanced to human tissue are
available from NeilMed.TM. Products located in Santa Rosa, Calif.
One packet size available contains approximately a 2.16 gram
mixture of substantially 39 parts NaCl and 1 to 2 parts
NaHCO.sub.3, and can be used to prepare an isotonic saline solution
having a concentration of approximately 0.9% to 1%, by dissolving
the contents of the packet into approximately 8 ounces of distilled
water. The same proportions of NaCl to NaHCO.sub.3 can conversely
be described as approximately 19.5 to 39 parts NaCl to 1 part
NaHCO.sub.3. A hypertonic saline solution can be prepared by
dissolving more than one packet of the NaCl/NaHCO.sub.3 mixture
into approximately 8 ounces of distilled water, or by mixing one
packet with less than 8 ounces of water. A hypotonic solution can
be prepared either mixing less than one packet of the
NaCl/NaHCO.sub.3 mixture into approximately 8 ounces of water, or
mixing one packet with more than 8 ounces of water.
Hypotonic, hypertonic, or isotonic saline solutions can be used for
rinsing and lavaging, with varying levels of comfort for the user
depending on the saline content of the solution. Negative
sensations can be caused by a saline solution prepared using home
ingredients, such as table salt, which results in a more acidic
solution that can cause burning. The NaCl/NaHCO.sub.3 packets
described above contain all natural and iodine free ingredients and
form an isotonic saline solution that is pH balanced to human
tissue the saline solution could typically come into contact with.
Such a "pH balanced" solution that is compatible with the human
tissue prevents burning or stinging during lavage or rinsing,
An aluminum lining can be used inside the packets to protect the
contents from moisture, which can adversely affect the ease with
which the NaCl/NaHCO.sub.3 dissolves in the water. A dotted line
can be marked on the exterior of the packet to provide a guide for
cutting open the packet.
The dispenser assembly 10 and saline solution 40 can be used to
perform a nasal, oral, throat or ocular rinse. Using the method
described below, a user of the dispenser assembly 10 can irrigate
human tissue, such as a nasal passage, oral cavity, throat or eye,
to remove mucus, allergens, and irritants. Starting with the cap 20
removed from the container 30, the container 30 is filled with
approximately eight ounces of water. A dashed line marked on the
exterior of container 30 indicates to a user when eight ounces of
fluid has been poured into the container 30. The water can then be
warmed in a microwave oven. The water can be warmed using
five-second increments to avoid excessive heating. If the water is
heated to hotter than lukewarm, it is recommended to allow the
water to cool before proceeding. Alternatively, the water can be
warmed before pouring it into container 30 or does not have to be
warmed at all.
A packet containing the NaCl/NaHCO.sub.3 mixture is cut open along
the dotted line and emptied into the container 30. The cap 20
having the tube 35 connected to the conduit 55 is secured onto the
container 30 by aligning the threads 60 of cap 20 with the threads
50 of neck 45 and screwing the cap 20 onto the neck 45 by gripping
the ridges 25 and rotating the cap 20 clockwise until fully
tightened. The dispenser assembly 10 is shaken until the
NaCl/NaHCO.sub.3 mixture is fully dissolved in the distilled
water.
To rinse a nasal passage, the user bends forward to a comfortable
level, tilting the head slightly down and applies the cap 20 snugly
against the left nostril with opening 15 directed into the left
nasal passage. The container 30 is squeezed to force the saline
solution 40 to enter the left nasal passage. The process is
repeated applying the cap snugly against the right nostril. The
saline solution 40 that was injected into the nasal passages will
drain from the nasal passages or the mouth and should not be
swallowed by the user. The user then gently blows the nose. Any
unused portion of the saline solution 40 is discarded and the
dispenser assembly 10 is cleaned. A nasal rinse can be performed
once or twice a day or as recommended by a qualified physician.
For oral irrigation, the user directs the saline solution 40 toward
the desired location in the mouth. The user then expels the excess
solution after the rinse has been employed. The user can also
squeeze the saline solution 40 into the mouth from the container 30
until the user has a mouthful of saline solution 40. The saline
solution 40 can be swished within the mouth. To rinse the throat,
the user directs the apparatus towards the back of the throat and
squeezes the container 30 to force the saline solution 40 towards
the throat. Alternatively, the user can take the solution from a
cup or mug. A user who is unable to take the solution on their own
can have the solution placed in his or her mouth with an apparatus,
such as, for example, a straw or oral syringe. The user can then
gargle or swish the solution in the mouth or throat. The user then
expels the saline solution 40. Users unable to expel on their own
can have the solution suctioned from their mouth and throat with an
aspirator. Oral irrigation can be performed at regular intervals to
relieve irritation, discomfort or foreign substances from the mouth
and throat.
Oral irrigation can be performed after meals, after tooth brushing
or as recommended by a qualified physician or dentist. Persons with
immunosuppressed conditions, severe systemic disease, or cancer
should maintain oral hygiene to prevent septimecia and control oral
complications related to their condition. Oral rinsing can aid in
maintaining good oral hygiene, and can also be prescribed for
treatment of periodontal disease, such as, acute and chronic
gingivitis or gum infections, treatment of tongue infections,
application post-surgery, promotion of post-trauma tissue healing
or treatment of oral lesions. Moreover, oral and nasal rinsing aids
in clearing bacteria from the mouth, throat and nose from healthy
individuals. Bacteria that generally reside in the mouth make-up
the normal oral flora. An abundance of bacteria can cause
aspiration of bacteria into the lungs, which can subsequently lead
to pneumonia and pneumonia related complications.
Throat irritation caused by allergies or illness can be relieved by
rinsing with the saline solution. Oral irrigation can be used to
clear food debris, dried mucus, pus at the site of ulcers, dead
tissue, bacterial and fungal colonies, blood clots and other
organic or inorganic substances that impede the maintenance of a
healthy system. Cleaning these substances out of the mouth can also
improve the odor of the breath.
For rinsing an eye, the dispenser assembly 10 can be used without
the tube 35. The user tilts his or her head back to facilitate the
acceptance of saline solution 40 into the eye. The user can gently
pull downward on the lower lid of the eye with a finger. With the
other hand, he or she then inverts the dispenser assembly 10 and
squeezes out the saline solution to force drops from the opening 15
into the eye. The opening can be directed at any part of the eye,
such as toward the conjuctiva, the sclera, or the opening formed by
pulling down on the lower eyelid. Ocular irrigation can clear
foreign substances from the eye and provide relief from eye
irritation. Clearing foreign substances from the eye for example,
such as, particles or chemicals, can prevent further damages
resulting from lack of treatment. Other uses, such as for rinsing
open wounds, can be achieved by directing the cap 20 of the
dispenser assembly 10 at the tissue, and squeezing the container 30
to release the saline solution 40.
In addition to human health care, animals can benefit from the use
of saline solutions. Dogs, cats and other animals suffer from
ailments which can be treated in a similar fashion to human
ailments. Therefore, a saline solution can be used to maintain or
improve the health of non-human animals.
The cap 20, tube 35 and container 30 should be thoroughly cleaned
after each use. The cap 20 can be sterilized by submersing it
briefly in boiling water. The tube can be cleaned by rinsing the
tube thoroughly with water and using a narrow brush to clean the
interior, such as the type of brush commercially available for
cleaning baby bottles. The container 30 can similarly be cleaned by
rinsing the container 30 with water and using an
appropriately-sized brush. A vinegar and water solution can also be
used to clean the dispenser assembly 10. Alternatively, the user
can rinse the apparatus with an anti-bacterial solution,
appropriate solutions can include a high concentration of isopropyl
alcohol or an equivalent anti-bacteria ingredient.
An alternative lavaging technique includes using a power operated
water jet dispenser designed for oral irrigation attached to a
dispenser tip suitable for nasal or oral irrigation. An oral
irrigator such as the Waterpik.RTM. Oral Irrigator manufactured by
The Waterpik Technologies Personal Healthcare Products Division of
Water Pik Technologies, Inc., based in Fort Collins, Colo., can be
used in conjunction with cap 20 and tube 35 to perform a nasal
lavage. Tube 35 has an inner diameter such that it can form a snug
fit connection to a water tube (not shown) forming part of the oral
irrigator. The flexibility of tube 35 permits compatibility to most
commercially available oral irrigators. The water reservoir element
of the oral irrigator is filled with a saline solution that can be
prepared using the method described above. The oral irrigator can
then be operated to drive the saline solution through the water
tube into tube 35 and out of opening 15 into a user's nasal
passage, oral cavity or throat.
Cap 90 can also be used in conjunction with an oral irrigator as
described above. A length of flexible tubing (not shown) can be
used as a coupling between conduit 56 and a water tube forming part
of the oral irrigator.
A number of embodiments of the invention have been described.
Nevertheless, it will be understood that various modifications may
be made without departing from the spirit and scope of the
invention. Accordingly, other embodiments are within the scope of
the following claims.
* * * * *
References